Creation of a drug fund for post-clinical trial access to antiretrovirals

Abstract

The long running debate about clinical trial sponsors’ responsibility for providing treatment to patients after a trial has ended does not seem likely to end soon. In September 2003 the World Medical Association postponed its decision about whether or not the Declaration of Helsinki should be revised to reflect concerns that the US government and the pharmaceutical industry have expressed about post-trial treatment. Paragraph 30 of the Declaration of Helsinki currently states: “At the conclusion of the study every patient entered into the study should be assured of access to the best proven prophylactic diagnostic and therapeutic methods identified by the study”. The proposed revision to paragraph 30 would introduce two main changes: that the physician should make every effort to see that patients receive treatment once it has been approved by appropriate authorities and that the physician is required to explicitly tell patients if they are unlikely to continue receiving treatment from sponsors after they leave the study. The ethical concerns over the undertaking of clinical trials in developing countries especially with respect to the standard of treatment that should be provided to trial participants have resulted in little research in countries where interventions are needed most. The initiation of preventative HIV vaccine trials has been delayed by debate about the provision of antiretrovirals to participants. (excerpt)